FCC ID: 2AB2MPECGT-III Pocket ECG Monitor

USER MANUAL PocketECG III DUAL CHANNEL 0197 Warsaw 2014 revised: September 09, 2014 Copyright 2014 MEDICALGORITHMICS. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from MEDICALGORITHMICS. MEDICALGORITHMICS assumes no responsibility for any injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Manufactured by:

MEDICALGORITHMICS SA Al. Jerozolimskie 81, 02-001 Warsaw, Poland tel./fax.: +48 22 825 12 49 e-mail: technical@medicalgorithmics.com web: www.medicalgorithmics.com Page 2 of 118 TABLE OF CONTENTS 1. PocketECG III description 1.1. PocketECG III components 1.2. PocketECG III architecture 1.2.1. Transmission and analysis delay 1.3. Data transmission technologies 1.3.1. Mobile telephony network 1.3.2. Encrypted internet channel 1.3.3. Micro SD card (optional) 1.3.4 Information to user 2. Symbols glossary 3. Warnings and cautions 3.1. Warnings 3.1.1. PocketECG transmitter 3.1.2. PC client application 3.2. Cautions 4. Intended use 5. Contraindications 6. Accessories A. POCKETECG TRANSMITTER 7. Handling the device and its accessories 7.1. Starting the device 7.2. Main and backup batteries 7.2.1. Main battery charging 7.2.2. Backup battery charging 7.3. Stopping the device 7.4. SIM and flash memory cards 8. Test preparation 9. Supervisor and patient views 9.1. Supervisor view 9.1.1. Start/stop button 9.1.2. View tab 9.1.3. Settings tab Page 3 of 118 9.2. Patient view 9.3. Method for calculating pause and heart rate 10. Alarms 11. Data structure and transmission to the remote server 12. Maintenance 12.1. Inspection of the device 12.2. Testing the device 12.3. Cleaning the device 12.4. Storing the device 12.5. Software updates 13. Safety rules for using the PocketECG transmitter 13.1. Electromagnetic compatibility (EMC) B. PC CLIENT SOFTWARE 14. Equipment requirements 15. Installation 16. Distribution 17. Overview 17.1. Communication with remote server 18. Navigator 18.1. Introduction 18.2. Navigator toolbar 18.3. Adding and editing patient and specialist data 18.3.1. Patients 18.3.2. Specialists 18.3.3. Relations between specialists, patients and PocketECG transmitters 18.4. Assigning patients / specialists to recording session 18.5. Downloading and removing recording session data 18.6. Remote communication with the transmitter 18.7. Communication with the SD card through USB 19.Event View 19.1. Introduction 19.2. Filtering and sorting of the events list 19.3. Events reviewing Page 4 of 118 19.4. Navigation through the ECG recording 19.5. ECG display settings and transmitter settings 20. Full Disclosure 20.1. Introduction 20.2. Navigation through the ECG recording 20.3. ECG display settings and re-annotations 21. Trends 21.1. Acceleration trend 22. Impressions and Findings 23. Reports 23.1. Introduction 23.2. Reports viewing 23.3. Reports editing 24. Garbage 25. Archive 26. Tools Menu C. ADDITIONAL INFORMATION 27. Medical incident 28. Troubleshooting 29. Technical parameters 30. Service 31. Declaration of conformity 32. Limited warranty statement 33. Software license agreement Page 5 of 118 1. POCKETECG III DESCRIPTION 1.1. PocketECG III components The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III consists of:

PocketECG transmitter, model: PocketECG III, type: PECGT-III with the following accessories:

o Two rechargeable batteries, type: PECGB-III, o The AC plug-in battery charger, type: PECGC-III, PC Client software User manual (hardcopy) for the patients The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III is compliant with:

the essential requirements of the Council Directive 93/42/EEC, the requirements of the United States Food and Drugs Administration. the requirements of the Health Canada Medical Devices Regulations. This user manual describes PocketECG transmitter, its accessories and PocketECG PC client software. 1.2. PocketECG III architecture The functional block diagram of PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System in combination with the data transmission to the remote server is presented in Fig. 1. Page 6 of 118 Fig. 1 Functional block diagram of PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System The patient heart activity is digitized using a PocketECG transmitter. The transmitter is equipped with digital accelerometer, generating signals corresponding to the patient physical activity. An algorithm, operating on the PocketECG transmitter automatically analyzes the acquired ECG in real-time and transmits both: the ECG and acceleration data to the remote server accessible by a Monitoring Center for reviewing by trained medical staff. The ECG data comprises of ECG annotations for all detected heart beats and the entire ECG signal. The acceleration data comprises of results of patient activity estimation Page 7 of 118 along with the waveforms of the acceleration signals. All detection results along with the waveforms of the ECG and acceleration signals may be reviewed using a PocketECG Client - PC based application. Optionally, the ECG and acceleration data may be downloaded to the Pocket ECG Client application from the SD card of PocketECG transmitter using standard SD card reader connected to the PC through USB interface. 1.2.1 Transmission and analysis delay The ECG signal is interpreted by the software of PocketECG transmitter with few seconds delay, which is relatively quick considering the monitoring duration of a patient i.e. which may last from one day to several weeks. Therefore analysis with such short delay is considered as performed in real-time. The transmission of data chunks is also performed fairly frequently, with regard to the potential monitoring. The use of this approach is to provide the arrhythmia analysis results to the physician with short delay on an ongoing basis, which allows for making a decision whether monitoring should be carried on (in order to collect more data) or whether it should be terminated, assuming that conclusive results were generated. This is beneficial for the patient, who do not have to wear the device unnecessarily and also allows for limiting the cost of monitoring no need to transmit and analyze unnecessary data. In the worst case conditions, which are lack of mobile network signal, the data will not be transmitted at all. However, acquired data is stored on the micro SD card and can be optionally downloaded to the PC using wired USB connection when the recording session is finished (micro SD card reader is required). In case of limited access to the mobile network, the data may be transmitted when the patient is in the network range limited times per day. Therefore the user has to be aware of limitations related to monitoring and transmission using a mobile network infrastructure. The ECG signals are presented on the device screen about 1 second after they are sampled by the PocketECG transmitter. Page 8 of 118 The PocketECG transmitter initializes the data transmission to the remote server:

1. at least every 75 minutes, 2. when the ECG event/abnormality is detected, 3. when "Report symptoms" button is pressed by the patient. The PC Client software polls the remote server every 30 seconds. If new data related to the selected recording session are available, the PC Client downloads them automatically. In order to download data stored on the micro SD card of the PocketECG transmitter, the card must be removed from the transmitter and inserted into the USB micro SD card reader. The PC Client user may request to download the data from the micro SD card when successful USB connection between micro SD card reader and PC is already established. 1.3. Data transmission technologies The description of the data transmission technologies utilized by the PocketECG device is given in the following subsections. 1.3.1 Mobile telephony network The Pocket ECG transmitter is equipped with communication module providing access to mobile telephony network (quad band GSM EDGE, UMTS 850 / 1900 / 2100MHz Diversity (850, 1900MHz)). The wireless data transmission technologies used by the mobile telephony network carriers like: GPRS, EDGE, HSDPA, HSUPA, are utilized to transmit the ECG and acceleration data along with the results of automated signals analysis to the remote server. The exact technology used for data transmission depends on its availability. The data transmission is triggered automatically based on results of the automated ECG signal analysis, manually by the patient or Page 9 of 118 periodically. The data transmission is initiated immediately after detecting irregularities in the ECG signal or after pressing the "Report symptoms" button on the transmitter by the patient (refer to Section 9.2 for detailed description). Otherwise, the data transmission is triggered at least once every 75 minutes. Depending on the transmission quality of service the time needed to upload patient related data to the remote server may vary. There is no minimal rate for data upload required for proper operation of the PocketECG. However, a user must be aware that when the data rate is extremely low the period of time required to transmit the data may be very long. Therefore, it is recommended to ensure that the mobile network allows data uploading with at least 10 kbps (average) on the area where the patient is going to be monitored. It is easily achievable in most of the existing mobile networks in the US/EU. The PocketECG transmitter only transmits ECG and acceleration data along with automatic analysis results related to a specific recording session ID. The session ID is a unique identifier which consists of the timestamp of the session start with 1 second accuracy and the unique ID of the PocketECG transmitter. No personal data is entered on the PocketECG transmitter nor transmitted through mobile telephony network. The connection to the server comprises TCP/IP sockets and is based on the transfer of the data files. 1.3.2. Encrypted internet channel The internet encrypted channel is used by the PC client application for reviewing the ECG and acceleration data that was sent to the remote server by the patient monitors (PocketECG transmitter). Since the data which is exchanged between the PC Client and the server includes personal data, all of the communication channels need to be encrypted. The PocketECG III uses a SSL-like authentication, authorization and encryption mechanisms. The encrypted data is transmitted over TCP/IP sockets in a binary form. The symmetric key exchange algorithm uses the RSA cryptographic model while the block encryption utilizes Triple Data Encryption Algorithm (TDEA). The recommended minimal download and upload speed of the internet Page 10 of 118 connection is 512 kbps and 64 kbps, respectively. The internet connection of a lower speed may also be used. However, the user must be aware that the access and reviewing of the ECG and acceleration data stored on the remote server will be more time-consuming. Only the server listens on TCP/IP sockets to accept incoming connection requests. Neither the PocketECG transmitter nor the PC Client need to open any ports, so the incoming connection rules dont have to be changed in the firewall software. If the PC Client is installed in an environment which filters the outbound traffic, a rule which enables connecting to the remote TCP port needs to be added to the firewall software. 1.3.3. Micro SD card (optional) The PocketECG transmitter is not equipped with USB connector. It does not have any external connector and cannot be connected to any other electronic equipment. The only data path for ECG and acceleration data goes through mobile phone link between PocketECG transmitter and a remote server. The ECG and acceleration data processed by the PocketECG transmitter are:

1) stored on the flash memory card (microSD) of the PocketECG transmitter, 2) transmitted using cellular networks technology to the remote server. In some circumstances like:

no cellular phone service on the area where the patient is monitored mobile network failure problems with internet connection on the PC with PC Client application installed - data cannot be downloaded from a remote server Page 11 of 118 the data may be downloaded from the micro SD card to the PC using card reader. The card reader either integrated with PC (most laptops do have them) or connected to the PC through USB 2.0 interface may be used. The data can be downloaded by the medical staff providing the service to the patient when the recording session is already finished. The USB transmission should be performed using wired connection established between USB card reader and PC. The micro SD card must be removed from the PocketECG transmitter and inserted into the socket of USB card reader. The communication based on the file transfer is safe as no personal data is stored on micro SD card. 1.3.4 FCC Requirements FCC id: 2AB2MPECGT-III This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications of any kind not expressly approved by Medicalgorithmics SA could void the uses authority to use ECG. Page 12 of 118 2. SYMBOLS GLOSSARY The following symbols appear on the label placed on the PocketECG transmitter's casing and in this user manual:

0197 Symbol indicating compliance of the PocketECG device with the main requirements of Council Directive 93/42/EEC. Symbol indicating that the PocketECG transmitter is BF type equipment. Manufacturers symbol manufacturers name and address is placed next to this symbol. Symbol indicating date of manufacture of the PocketECG transmitter Symbol indicating necessity to read user manual of the PocketECG III. Caution/Notices read carefully Warning read carefully Symbol indicating that the PocketECG transmitter includes a radio wave transmitters. Symbol indicating that the PocketECG transmitter fulfils the requirements of the FCC (Federal Communication Commission) Symbol indicating that it is a medical device Page 13 of 118 IP20 IP02 that needs to be protected from moisture. Symbol indicating that the transmitter is protected against solid particles up to 12,5 mm (fingers or similar objects) but it is not protected against liquid ingress. Symbol indicating minimum protection class of protective case that can be used with PocketECG III transmitter. It is marked on the protection case intended to be used in outdoor applications of PocketECG III transmitter. Symbol indicating that it is necessary to dispose of the PocketECG transmitter in compliance with appropriate regulations. Symbol indicating that the PocketECG transmitter poses hazards in all MR

(Magnetic Resonance) environments PECGT-III Transmitter type Serial number of the PocketECG transmitter The following symbols appear on the label placed on the PocketECG accessories (charger and/or battery) and in this user manual:

Symbol indicating recyclable materials Page 14 of 118 Indoor use only Symbol indicating direct current Symbol indicating alternating current Symbol indicating date of manufacture of the charger/battery Symbol indicating Class II equipment Symbol reflecting behavior of the charger light indicators - all light indicators are turned on and emit green light (battery fully charged) Symbol reflecting behavior of the charger light indicators - one or more light indicators are turned on and emit orange light

(charging in progress) Symbol reflecting behavior of the charger light indicators - all light indicators blinks and emit orange light (no battery in the compartment) Symbol indicating that particular action has to be taken in order to stop the charger from emitting sound PECGC-III Charger type Page 15 of 118 PECGB-III Battery type Serial number of the charger/battery Page 16 of 118 3. WARNINGS AND CAUTIONS This section is to familiarize the user with applicable warnings and cautions. Specific warnings and cautions can also be found in other sections of the user manual. 3.1. Warnings Warning statements alert to situations which, if not avoided, could result in illness or injury of the patient. 3.1.1. PocketECG transmitter WARNING. THE POCKETECG TRANSMITTER DOES NOT PROTECT AGAINST DEFIBRILLATION EFFECTS AND MAY BE DAMAGED IF PLACED ON A PATIENT UNDERGOING DEFIBRILLATION. REMOVE ELECTRODES, PATIENT LEAD WIRES, AND THE POCKETECG TRANSMITTER FROM PATIENT BEFORE DEFIBRILLATION. WARNING. THE POCKETECG TRANSMITTER DOES NOT DISTURB THE PACEMAKER OPERATION. HOWEVER, FOR PATIENTS WITH A PACEMAKER, MAINTAIN A MINIMUM DISTANCE OF 6 INCHES BETWEEN THE TRANSMITTER AND PACEMAKER. TURN THE TRANSMITTER OFF IMMEDIATELY AND PROVIDE APPROPRIATE PATIENT CARE IF YOU SUSPECT THE TRANSMITTER AFFECTED THE PACEMAKER. WARNING. THE POCKETECG TRANSMITTER IS NOT INTENDED FOR INFANTS WEIGHING LESS THAN 10 KG. WARNING. THE POCKETECG TRANSMITTER IS NOT INTENDED FOR USE IN INTENSIVE CARE UNITS. IT SHOULD NOT BE USED WITH HIGH FREQUENCY SURGICAL DEVICES OR DIRECTLY ON THE HEART. Page 17 of 118 WARNING. DISCARD ELECTRODES AFTER EACH USE. WARNING. DO NOT USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR OXYGEN OR NITROUS OXIDE. WARNING. TO AVOID DANGER OF SWALLOWING KEEP THE POCKETECG TRANSMITTER PARTS AND ITS ACCESSORIES AWAY FROM BABIES AND CHILDREN. WARNING. DO NOT USE ACCESSORIES OTHER THAN THOSE RECOMMENDED BY THE MANUFACTURER. IT MAY BE DANGEROUS TO THE USER AND MAY AFFECT ELECTROMAGNETIC COMPATIBILITY OF THE POCKETECG TRANSMITTER. WARNING. THE POCKETECG TRANSMITTER CONTAINS A LITHIUM-ION BATTERY. THERE IS A RISK OF FIRE AND BURNS IF THE BATTERY PACK IS HANDLED IMPROPERLY. DO NOT ATTEMPT TO OPEN OR SERVICE NEITHER THE BATTERY PACK NOR TRANSMITTER. DO NOT DISASSEMBLE, CRUSH, PUNCTURE, AND SHORT EXTERNAL CONTACTS OR CIRCUITS, DISPOSE OF IN FIRE OR WATER, OR EXPOSE TO TEMPERATURES HIGHER THAN 60 C (140F). REPLACE ONLY WITH BATTERIES SPECIFIED BY THE DEVICE MANUFACTURER. RECYCLE OR DISPOSE OF USED BATTERIES ACCORDING TO THE LOCAL REGULATIONS OR REFERENCE GUIDE SUPPLIED WITH YOUR PRODUCT. WARNING. DO NOT USE THE POCKETECG TRANSMITTER AT GAS STATIONS, FUEL DEPOTS, CHEMICAL PLANTS OR WHERE BLASTING OPERATIONS ARE IN PROGRESS, OR IN POTENTIALLY EXPLOSIVE ATMOSPHERES SUCH AS FUELLING AREAS, FUEL STOREHOUSES, BELOW DECK ON BOATS, FUEL OR CHEMICAL TRANSFER OR STORAGE FACILITIES, AND AREAS WHERE THE AIR CONTAINS CHEMICALS OR PARTICLES, SUCH Page 18 of 118 AS GRAIN, DUST, OR METAL POWDERS. THE USER SHOULD OBSERVE RESTRICTIONS ON THE USE OF RADIO EQUIPMENT IN SUCH PLACES. PLEASE BE AWARE THAT SPARKS IN SUCH AREAS COULD CAUSE AN EXPLOSION OR FIRE RESULTING IN BODILY INJURY OR EVEN DEATH. WARNING. NEITHER THE POCKETECG TRANSMITTER NOR ITS ACCESSORIES ARE WATERTIGHT. PREVENT THE POCKETECG EQUIPMENT FROM GETTING WET. KEEP THE DEVICE IN DRY CONDITIONS WHEN SHOWERING, BATHING OR WASHING. WARNING. IN ALL OUTDOOR APPLICATIONS POCKETECG TRANSMITTER MUST BE KEPT IN THE PROTECTIVE CASE WITH PROTECTION CLASS AT LEAST IP02. THE POCKETECG TRANSMITTER CAN BE USED WITH THE PROTECTIVE CASE AVAILABLE FROM THE MANUFACTURER OR ANY OTHER WITH PROTECTION CLASS AT LEAST IP02. WARNING. POCKETECG III HAS BEEN TESTED AND MEETS FCC RF EXPOSURE GUIDELINES WHEN USED WITH AN ACCESSORY THAT CONTAINS NO METAL AND THAT POSITIONS THE HANDSET A MINIMUM OF 1.0CM FROM THE BODY. USE OF OTHER ACCESSORIES MAY NOT ENSURE COMPLIANCE WITH FCC RF EXPOSURE GUIDELINES. DO NOT USE THE DEVICE IN A MANNER SUCH THAT IT IS IN DIRECT CONTACT WITH THE BODY 3.1.2. PC client applications WARNING. THE PC CLIENT APPLICATIONS ARE NOT INTENDED FOR USE IN INTENSIVE CARE UNITS. WARNING. THE PC CLIENT SOFTWARE IS NOT INTENDED FOR INFANTS WEIGHING LESS THAN 10 KG. Page 19 of 118 WARNING. DEVICE OPERATING PC CLIENT APPLICATIONS SHOULD BE USED IN THE TEMPERATURE RANGE DEFINED BY THE MANUFACTURER. WARNING. DO NOT USE DEVICE OPERATING PC CLIENT APPLICATION IN GAS STATIONS, FUEL DEPOTS, CHEMICAL PLANTS OR WHERE BLASTING OPERATIONS ARE IN PROGRESS, OR IN POTENTIALLY EXPLOSIVE ATMOSPHERES SUCH AS FUELLING AREAS, FUEL STOREHOUSES, BELOW DECK ON BOATS, FUEL OR CHEMICAL TRANSFER OR STORAGE FACILITIES, AND AREAS WHERE THE AIR CONTAINS CHEMICALS OR PARTICLES, SUCH AS GRAIN, DUST, OR METAL POWDERS. THE USER SHOULD OBSERVE RESTRICTIONS RELATED TO THE USE OF RADIO EQUIPMENT IN SUCH AREAS. BE AWARE THAT SPARKS IN SUCH AREAS COULD CAUSE EXPLOSION OR FIRE AND MAY RESULT IN BODY INJURY OR EVEN DEATH. 3.2. Cautions Caution statements alert to situations which, if not avoided, may result in equipment failure, equipment damage, or data loss. Caution. Prior to starting a diagnostic session read the PocketECG device manual carefully. Caution. US Federal Law restricts this device to sale by or on the order of a physician. Caution. The ECG cables should not be bent, pulled and wrapped around the device. Caution. The batteries should be charged before the first usage. Page 20 of 118 Caution. Inspect the device and all accessories before each use (see section 12). Page 21 of 118 4. INTENDED USE The PocketECG transmitter constitutes a part of the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and is intended to:

acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patients body with three electrodes. The device is battery powered from Lithium-ion battery with rated voltage of 3.7 V and is designed for continuous use. The results of arrhythmia and ST elevation detection are displayed, stored or/and transmitted along with ECG signals. The acceleration signals are analyzed in order to determine the physical activity of patient. It is assumed that the device can further transmit the ECG and acceleration signals along with analysis results using available wireless technologies. The PocketECG III is intended for use under supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. Having fulfilled the working conditions specified in the manual, the device may be used when the patient is in the following places: clinic, hospital, outpatient cardiology clinic, house, business establishment, etc. The PC client software is used for reporting and reviewing ECG/arrhythmia diagnostic sessions. The reviewed ECG and acceleration data is being transmitted from patients PocketECG transmitter, through mobile telephony network to a remote server. The PC client software connects with the remote server and downloads the data which can then be viewed locally. The PC client software allows for reviewing of the ECG and acceleration signals along with the Page 22 of 118 annotations and creating the reports summarizing the recording session results. 5. CONTRAINDICATIONS The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III, which consists of the PocketECG transmitter, and/or PC client software is not intended to be used by patients who have been diagnosed with life threatening arrhythmias and require hospitalization or patients who require inpatient monitoring using a life-saving device. The Pocket ECG III is not intended for use in surgical rooms, intensive care units, intermediate or step-down units, emergency vehicles. The PocketECG III is MR unsafe and should not be used in any magnetic resonance environment. 6. ACCESSORIES The following accessories are provided by the manufacturer in a package with the PocketECG transmitter:

A Lithium-ion battery pack providing rated voltage of 3.7 V, type: PECGB-III, with capacity of 1700 mAh. Use only battery of this type. AC plug-in charger type PECGC-III suitable for charging PECGB-

III type batteries. WARNING. UNDER NO CIRCUMSTANCES THE DEVICE MAY BE PLUGGED TO A DIFFERENT SOURCE OF POWER THAN INTENDED BY THE MANUFACTURER. USING A DIFFERENT POWER SOURCE IS HAZARDOUS AND MAY IMPAIR FUNCTIONING OF THE EQUIPMENT OR RESULT IN SERIOUS INJURY TO THE USER. WARNING. IN ALL OUTDOOR APPLICATIONS POCKETECG TRANSMITTER MUST BE KEPT IN THE PROTECTIVE CASE WITH Page 23 of 118 PROTECTION CLASS AT LEAST IP02. THE POCKETECG CAN BE USED WITH THE PROTECTIVE CASE AVAILABLE FROM THE MANUFACTURER OR ANY OTHER WITH PROTECTION CLASS AT LEAST IP02. The following other accessories are needed for proper operation of the device but are not enclosed in the PocketECG transmitter package:

micro SD memory card SIM card ECG electrodes Page 24 of 118 A. P OCKE TECG TRA NSMI TTE R The PocketECG device (see Fig.2) transmits both the ECG and acceleration signals along with the results of their analysis to a remote server. Fig. 2 PocketECG transmitter The features of the PocketECG transmitter are as follows:

processing of two ECG channels Page 25 of 118 3-axis accelerometer - physical activity of patient is estimated basing on analysis of acceleration signal 320x480 color display with touch panel micro SD / SDHC card socket SIM card socket backup power - main battery may be replaced without interrupting recording session 7. HANDLING THE DEVICE AND ITS ACCESSORIES CAUTION. A PATIENT SHOULD BE TRAINED BY A QUALIFIED PERSONNEL BEFORE USING THE POCKETECG TRANSMITTER. 7.1. Starting the device To start the PocketECG transmitter slide the battery into its compartment, until it snaps shut (Fig. 3). Page 26 of 118 Fig. 3Battery inserting After the battery is placed in the appropriate compartment of the PocketECG transmitter, the device turns on automatically. The device is ready for starting new recording session about 30 seconds after the battery is placed in its compartment. A graphical user interface comes on when the device is properly supplied with power and ready to work. Caution. If no image is displayed within 30 seconds after placing the battery in the compartment, the battery is fully discharged or device does not operate correctly due to the abnormal temperature or humidity conditions. Page 27 of 118 7.2. Main and backup batteries A fully charged battery makes it possible to continuously monitor the patient's ECG and acceleration signals using the PocketECG transmitter for at least 24 hours. In order to replace the battery follow the instructions (see Figs. 4):

1. Slide the battery lock to release the battery;

2. Remove the battery;

3. Place fully charged battery until the lock clicks back into its original position;

Caution. When replacing the battery, make sure the contacts face the interior of the battery compartment. If slipping the battery in requires excessive force, check if you are putting it into the case the right way. The PocketECG transmitter is equipped with backup battery that is intended to supply the device when the main battery is being replaced. Removing main battery when the recording session has not been initiated or has already been finished does not activate backup power

(the device turns off). When the main battery is being removed during ongoing session, the transmitter operates continuously for up to 5 minutes powered from backup battery. After placing fully charged main battery into its compartment, the transmitter starts to be powered from main battery automatically. Caution. The backup power is activated only when recording session is ongoing. Caution. If the level of main battery is low, replace it with fully charged one, immediately. If the main Page 28 of 118 battery remains removed from its compartment for period longer than 5minutes, the transmitter is switched off and the transmission is suspended. 7.2.1 Main battery charging The discharged battery should be charged immediately if the diagnostic session is intended to be performed for a period longer than 24 hours. On average the battery requires 4 hours to be fully charged. Use charger provided along with PocketECG transmitter. If the device is not going to be used for a longer time period, remove the battery. Fig. 4Replacing battery in the PocketECG transmitter Page 29 of 118 When the battery gets damaged or worn out, follow standard disposal procedure for Lithium-ion batteries. Caution. The AC plug-in charger may require suitable adapter and/or converter to convert to the proper voltage when used outside the territory of a country where it was provided by the Medicalgorithmics distributor. WARNING. DO NOT USE OTHER CHARGERS THAN THOSE INTENDED FOR THE TYPE OF BATTERY USED IN THE POCKETECG TRANSMITTER IN ORDER TO PREVENT DANGER OF BATTERY EXPLOSION. In order to charge the battery, follow the instructions:

1. Plug the charger into the AC mains;

2. Check whether a sound is generated indicating ready to use state of the charger;

3. Put the battery into the charger cradle and verify whether light indicator flashes orange indicating that the charging is in progress;

4. Wait until the light indicator of the charger changes from orange to indicating that the battery is fully charged. 7.2.2 Backup battery charging The backup battery is installed inside the PocketECG transmitter and cannot be removed. The charging of the backup battery is started automatically and does not require interaction from the user. The charging of backup battery is initiated when its state of charge falls below predefined level and the main battery powering the device is fully charged. Therefore, the discharged main battery should be always replaced with a fully charged one. Page 30 of 118 7.3. Stopping the device In order to switch the transmitter off ensure that the recording session is finished and remove the battery from its compartment. 7.4 SIM and flash memory cards The PocketECG transmitter is equipped with a socket for a SIM and micro SD memory cards (see Fig. 5). The ECG and acceleration data are stored on SD card during recording session and further transmitted through mobile telephony network to a remote server. The SIM card is required in order to allow data transmission through a mobile telephony network. This card is provided by the mobile network operator. If your transmitter is not already equipped with SIM card please contact your PocketECG service provider for assistance. In case of limited access to mobile telephony network data are stored on SD card until they can be successfully transmitted. It is recommended to use reliable SD cards of minimum 1 GB capacity produced by the Verbatim, SanDisk and other experienced manufacturers. The PocketECG transmitter operates with the micro SD and micro SDHC (high capacity) cards. Caution. The SIM and micro SD cards must be placed in its compartment before new recording session is started. 8. TEST PREPARATION Only high quality electrodes with fast conducting gel should be used with the PocketECG transmitter. We recommend using electrodes designed for Holter monitoring. Single-use electrodes last for a limited time period and should not be used for longer than specified by their manufacturer. Fresh electrodes contain wet gel; if the gel is spongy the Page 31 of 118 electrodes are of poor quality or past their use-by date. Usually, electrodes last no longer than 2-3 weeks after opening the box. Caution. Verify the use-by dates on applied electrodes to make sure they have not expired. Caution. ECG electrodes can cause skin irritation. Examine the skin for signs of irritation or inflammation and avoid placing of the electrode in those areas. WARNING. THE SNAPS OF THE ECG LEAD WIRES ARE MADE OF METAL CONDUCTING THE CURRENT AND ARE INTENDED TO BE CONNECTED WITH ELECTRODES PLACED ON A PATIENT'S BODY. THE SNAPS OF THE LEAD WIRE SHOULD BE CONNECTED NEITHER TO ANY OF THE POCKETECG ACCESSORIES NOR OTHER EQUIPMENT. NEVER CONNECT THE LEAD WIRE SNAPS WITH ANY SOURCE OF ELECTRIC POWER SUCH AS POWER OUTLETS, POWER SUPPLIERS AND BATTERIES. A special preparation should be applied to patients skin before placing the electrodes. Do not use high-proof alcohol as it may dry up the epidermis and distort the ECG signal transmitted by the PocketECG device. In order to prepare patients skin follow these instruction:

1. Explain the procedure to the patient;

2. Remove hair from the place where the electrode is to be attached;

3. Degrease and prepare the skin;

4. Place the electrodes on patients body and connect the ECG cables of the PocketECG transmitter as shown in Figs. 5. Caution. Always make sure that the electrodes are placed correctly. Page 32 of 118 RED YELLOW WHITE BLACK GREEN RED Fig. 5 Connecting ECG cables of the PocketECG transmitter to electrodes on patients body (cable clips colors complying with the EU requirements - left, US requirements - right) 5. Secure each lead wire. Cables of the PocketECG device should be attached to the electrodes in a way that reduces movements causing signal artifact. When the amplitude of the ECG recording is very low (below 0.5 mV), we recommend gently wiping the epidermis with a very fine, disinfected, special sandpaper or putting the electrodes in a new place. Transmitting signal at a level lower than indicated could negatively impact its analysis. When electrodes are connected to the PocketECG transmitter as shown in Fig. 5 it is possible to monitor limb lead II and III. Green (red in case of US) cable snap is attached to a referential electrode of both ECG leads. Physician may order monitoring other profiles. 9. SUPERVISOR AND PATIENT VIEWS There are two main views of the graphic user interface: supervisor and patient. The 'supervisor view' is intended to be used by the medical staff and provides access to all options of the software. The 'patient view' is presented to the patient during entire recording session and gives only limited access to software functions. Page 33 of 118 9.1. Supervisor view The graphical user interface presented to the user in the 'supervisor view' mode is shown in Fig. 6. The waveforms of recorded ECG signals together with annotations generated by the analysis algorithm are plotted in three rows. Each row corresponds to six seconds of recording. Basing on displayed signals and annotations trained user may verify the proper electrode placement and proper initialization of the recording session. Furthermore, the heart rate in beats per minute is presented in the upper right corner of the screen. There are three tabs located in the bottom of the screen providing access to the software options:

Stop/Start used for starting and finishing of the recording session, View channel selection, signal scaling, etc. Settings session settings The icons indicating the battery level and signal strength of the mobile network are displayed in right bottom corner of the screen. Detailed description of these both indicators is given in the section 9.2. Page 34 of 118 Fig. 6 'Supervisor view' of the graphical user interface 9.1.1. Start/stop button The Start/Stop button enables starting and finishing recording sessions. When session is not yet initiated the button is displayed as a

"Start" button. Otherwise, the button is marked with "Stop" command -

when pressed cause the recording session to finish. When the recording session begins the ECG signal is displayed on the screen along with annotations of the classified beats and arrhythmias. The patients heart rate is displayed in the top right corner of the screen of the PocketECG transmitter. After starting a new recording session, verification of electrodes placement should be performed. In order to verify the electrodes placement, follow the instructions:

1. Make sure that colors of the ECG clips correspond to those presented in Fig. 5a (EU) or 5b (US). 2. Verify the ECG signal quality for both available channels by observing the ECG signal waveform on the screen. Caution. If the ECG signals are not presented on the PDA display and/or the "EL" annotation is displayed, the ECG signal is not analyzed due to the overload of the PocketECG transmitter or incorrect connection between lead wires and patient's electrodes. The similar effect may occur when ECG electrodes are used and should and signal quality is insufficient. 9.1.2. View tab The View tab contains the following options:

Page 35 of 118 Patient view - switches the user interface into the 'patient view'

Resize ECG - switches the length of the ECG waveforms displayed on the screen Zoom in amplitude doubles the ECG amplitude zoom, Zoom out amplitude reduces the ECG amplitude zoom by half. Reset zoom restores the default amplitude zoom of the ECG signal, Switch ECG channel switches between the first and the second ECG channel to be displayed on the device screen, The user may select whether small or large ECG waveforms should be displayed (see Fig. 7). Fig. 7 Small (left) and large (right) ECG waveforms Small waveforms correspond to 18 seconds of ECG signal (each row corresponds to 6 seconds). When 'large ECG waveform' mode is selected, 6 seconds of signal is presented in the top of the screen. Additionally, zoomed waveform corresponding to 3 seconds of ECG is presented below. 9.1.3. Settings tab Analysis settings can be accessed any time during software operation. The Settings tab contains following options:

Page 36 of 118 Arrhythmia Settings parameters for arrhythmia classification:

o Pause: N ms pause above N milliseconds , o Asystole: above N ms asystole above N milliseconds, o Bradycardia: below N BPM bradycardia below N beats per minute, o V tachycardia: above N BPM ventricular tachycardia above N beats per minute, o SV tachycardia: above N BPM supraventricular tachycardia above N beats per minute, o Premature: above N % - premature ectopic beats above N

%

o Multiform: sensitivity N N level of sensitivity for detection of multiform ventricular events, o Pacer: On/Off pacemaker switched on/off. Session Settings - configuration of the PocketECG transmitter:

o Power saving when set the device is automatically switched to power saving mode after a short period of inactivity on the patient view (display is off, etc.), o Send ECG events through Internet ECG events are transmitted when this option is selected (default), o Stream ECG and annotations ECG data are streamed to the remote server when this option is selected (default is off), o ECG strip at least every N minutes ECG transmission is triggered at least once every N minutes, o Comm. srv remote server address and port number, where processing results and signals are sent, o Ftp srv remote server address, Page 37 of 118 o Path: /XXX remote server folder name, o User name: - name of the user logging in to remote server o Password: ******* - hidden password area showing whether password was entered, o Restore Defaults button for restoring standard remote server settings. About - contains following options:

o Software version - displays version of software operating PocketECG transmitter, o Session info - displays window with following information related to the recording session:

- COM: [ xxx ][ nnnnnnn ][ nnnnnnnnn ] communication status (first brackets from the left), the number of files transmitted to the server (second brackets from the left), the number of files queued for transmission (third brackets from the left)

- TIME: DDd HHh MMm SSs time elapsed since the beginning of the session (DAYS HOURS MINUTES SECONDS),

- MEM: XXXXX MB free: space available on the micro SD memory card ID: YYYYMMDDHHMMSS_XXXXXXXXXXXXXXXXX():

Unique session ID. Page 38 of 118 Caution. The first bracket of the communication text field informs about the status of the wireless connection between the PocketECG transmitter and the remote server. The '[OK]' text string indicates that the connection has been established successfully. Otherwise, an error code will be displayed. The settings related to the connection with the remote server (Comm. srv, Ftp srv, Path, User name, Password) are read-only. These parameters are configured automatically during the installation and are stored in the 'settings.xml' file. The user should not modify the settings.xml file unless instructed by the PocketECG service technical support. Caution. The PocketECG transmitter configures the connection with the remote server automatically. If any problems with the configuration occur, please contact your PocketECG distributor or service provider. Page 39 of 118 9.2. Patient view The graphical user interface should remain in the 'patient view' (see Fig. 9) when recording session was successfully initiated and electrode placement was verified by the medical staff. The patient has no access to the settings of the application and other information, when the graphical user interface is switched to the 'patient view'. Fig. 9 'Patient view' of the graphical user interface The logo of service provider as well as phone number to help desk is displayed on the top of the screen. In the middle of the screen a large

'Report Symptoms' button is displayed. The patient can press the

'Report Symptoms' button and then select the particular symptoms from the list (see Fig. 10). Patient have to indicate when symptoms occurred and afterwards symptom must be confirmed (Fig. 11). If the selected symptom is wrong the patient may modify it after pressing

'Modify' button. Otherwise, the selected symptom is confirmed automatically after 5 seconds. Page 40 of 118 Fig. 10 Symptoms list Fig. 11 Activity during symptom and symptoms confirmation screen There are two indicators displayed in the bottom of the screen:

battery level indicator indicator of strength of mobile network signal Page 41 of 118 Both indicators are accompanied with the textual information expressing the battery charge state and signal strength in percentage scale. Additionally, the color of the battery indicator represents its state of charge in the following way:

Icon color Battery level/status Green Yellow Red between 100 and 40%

between 40 and 20%

below 20%

Black & blinking device powered from backup battery Both indicators are also displayed in the 'supervisor view' in the right bottom corner of the screen (see Figs. 6 to 8). In order to switch to the 'supervisor mode' the service provider logo must be kept pressed for at least 3 seconds and then the unique code must be typed (see Fig. 12). Fig. 12 Terminal for entering the unlocking code Caution. The unlocking code is: 1 2 3 6. Page 42 of 118 9.3. Method for calculating pause and heart rate Pause is calculated using (as an input) QRS detection results. If a distance between consecutive QRS complexes exceeds predefined

(pause) threshold, then the beat label annotation is marked as pause. Heart rate is calculated using (as an input) QRS detection results. HR is calculated for minute intervals: If within the analyzed minute, there is a sufficient number of QRS complexes, then minutely HR value is a median value of R-R intervals within that minute. Practically at least 10 R-R pairs are required to calculate the heart rate. Page 43 of 118 10. ALARMS The PocketECG transmitter generates following alarms requiring user attention (see Fig. 13):

Alarm Description Action No memory card The micro SD card is not installed in its compartment and the session cannot be initialized. The PocketECG transmitter cannot connect to the mobile phone network - data cannot be transmitted. The battery is discharged. The data are not transmitted to the remote server. The PocketECG transmitter cannot find the battery No network Replace battery Insert battery ECG module error The ECG module malfunction. The PocketECG transmitter was turned off for over 12 hours. The device was turned off for over 12 hours. Would you like to continue Page 44 of 118 Install micro SD card or replace damaged one Keep the PocketECG transmitter in the area where mobile network is accessible. Replace the battery with the fully charged. Insert the battery to the PocketECG transmitter Turn off and then turn on the device. If the module still does not operate correctly, call service provider. Make sure, that you have to stop or continue secession, call service provider. Page 45 of 118 monitoring?

Connect Electrodes Electrodes contact loss. The ECG signal data are not transmitted to the remote server. Put on the electrodes to your body. Fig. 13 Warnings displayed by the PocketECG transmitter 11. DATA STRUCTURE AND TRANSMISSION TO THE REMOTE SERVER The PocketECG transmitter analyzes the ECG signal on a beat-by-beat basis. Each beat is annotated and described by the so-called beat annotation structure. The structure contains:

beat type annotation, arrhythmia type annotation, ST level elevation / depression in micro volts, for each ECG channel, PQRST shape coefficients, Noise level (in micro volts), ADC interference level (in micro volts), Page 46 of 118 Depending on the circumstances and signal characteristics, registered data can be sent to a remote server specified in the settings if the Send ECG events through Internet option has been selected. Signal is transmitted automatically based on the data analysis, or periodically or the transmission is triggered by the patient (by pressing the Report symptoms button. The data is transmitted via the mobile telephony network. Page 47 of 118 12. MAINTENANCE The PocketECG transmitter type: PECGT-III and battery charger type:

PECGC-III, manufactured by Medicalgorithmics S.A. are designed for 5 years continuous use if properly operated. After the devices have been used for 5 years it should be recycled according to the local recycling program or refurbished by the manufacturer. If you have any questions or problems please contact Medicalgorithmics S.A. service using contact details from section 30. Service. The capacity of the PocketECG Li-Ion battery decreases with normal use over time. The battery must be replaced with a new one after 300 charging cycles or after 2 years of using. The maximal life time of a particular version of PC Client software is determined either by support period provided by Microsoft for the latest version of MS Windows operating system, that is compatible with technical specification of a particular version of PC Client software, or by support period provided by Microsoft for the Microsoft.NET Framework version used to build a particular version of PC Client software, whichever expires first. 12.1 Inspection of the device Prior to starting a recording session, the user should check the device in accordance with the following instructions:

1. Inspect the patient cable bends, cuts and cracks on the case;

2. After placing the fully charged battery into its compartment check whether proper graphical interface is displayed;

12.2 Testing the device At least one a year the user responsible for efficient operation of the device, should check its functional efficiency and verify the correctness Page 48 of 118 of displayed messages and check the condition of the equipment, especially the cables by performing the following operations:

1. Connect ECG simulator (e.g. Netech MiniSim 1000 or similar) to the patient cable of the PocketECG transmitter and adjust typical parameters (heart rate, amplitude) of generated ECG signal;

2. Start a new recording session;

3. Check for normal appearance of the waveforms with appropriate amplitude and without excessive noise. Check if signal annotations are properly displayed. If ECG simulator allows for arrhythmia simulating you may decide to check whether they are properly detected (it will prove appropriate operation of the device);

4. Try to bend the patient cable simulating typical bending caused by patients movements and verify whether this causes distortions of the ECG signal. 5. Remove the main battery and check whether device operates without interruptions (device is switched to a backup power automatically). If the PocketECG transmitter falls or gets hit, a functional efficiency check should be performed by the patient (simply try to start new diagnostic session) or person responsible for efficient operation of the device according to the above instructions. If you suspect that something is wrong with the device contact the manufacturers service. Caution. Do not remove the casing of the PocketECG transmitter and do not attempt to repair the device if it does not function properly. This may damage the device. 12.3. Cleaning the device Page 49 of 118 The outer surface of the device and lead wires can be wiped with a wet soft cloth and soft soap dissolved in water or an alcohol-based disinfecting agent. The device should be cleaned appropriately for intended use and following procedures binding for the institution where the equipment is used. Caution. Do not let soap or water get inside the PocketECG transmitter. It is not waterproof. When cleaning or using the equipment, never get the cables and the connectors wet. Should the PocketECG transmitter get accidentally wet, dry it immediately (leave the device with removed battery cover in the warm and wet room for at least 24 hours). After drying turn the device on to check if it functions properly. Should you have doubts whether the device functions properly, contact the manufacturers service. 12.4. Storing the device Remove the rechargeable battery from the device before storing it. This prevents the battery from accidental discharge and reduces the risk of its damage. Observe the environmental storage conditions. See section 29 Technical parameters of PocketECG transmitter. 12.5. Software updates The software operating PocketECG transmitter should not be modified or updated by anyone except the manufacturer or technical staff responsible for its servicing. There are two methods for updating the software of the PocketECG transmitter:

The installer of new software version must be stored on the microSD card. After powering the device the installer is automatically launched. It removes previous version of the software and installs the new one. Page 50 of 118 The PocketECG transmitter must be connected to the computer using USB port available after casing removal. When the connection is successfully established, the software installer must be executed on the PC. The installer updates the software version in the PocketECG internal memory. Page 51 of 118 13. SAFETY RULES FOR USING THE POCKETECG TRANSMITTER 1. One device is intended to monitor only one patient at a time. 2. It is recommended for the device to work in room temperature. 3. Air in rooms where the device works should be free of caustic gasses, steam and dust. Although the device is powered from 3.7V and does not allow for power intake larger than 3A it is not guaranteed that it cannot produce spark which could initiate explosion. 4. The patient should check with the appropriate airline carrier to confirm that PocketECG transmitter which is similar to the regular mobile phone may be used on the airplane during take-off, flight and landing. 5. Due caution should be exercised when handling the device. It is necessary to avoid excessive stretching and sudden jerking of cables connecting the PocketECG transmitter with electrodes placed on patients body. 6. Parts that wear out and are intended for single use should be used in accordance with binding regulations and cannot be re-used. This especially concerns the electrodes placed on patients body, which should be replaced with new ones after no longer than 24 hours if the diagnostic session is to be continued. Users (physicians, patients, etc) are trained in this respect and are advised to get familiar with this instruction. 7. The ECG cable is permanently attached to the PocketECG transmitter. In case of damage, do not repair or replace it, because it may negatively influence the electromagnetic compatibility of the device. Damaged ECG cable can be replaced only by the manufacturers service. 8. Manufacturer is not liable for damage to the PocketECG transmitter caused by improper operation of the device or neglecting guidelines included in the user manual. Page 52 of 118 9. Manufacturer accepts liability for safe operation of the PocketECG transmitter, only when the device is used as intended and in accordance with the user manual. 10. The PocketECG QRS detection algorithm adapts to noise and disturbances level obscuring the signal, i.e. in case of higher noise level, the QRS detection procedure becomes less sensitive. The minimum QRS detection level is set to 0.16 mV. WARNING. THE RESULTS OF AUTOMATED ECG SIGNAL ANALYSIS MAY BE INACCURATE IF AMPLITUDE OF THE QRS COMPLEXES IS LOWER THAN 0.16 mV. 11. The capacity of the PocketECG Li-Ion battery decreases with normal use over time. The battery must be replaced with a new one after 300 charging cycles or after 2 years of using. 12. The conductive parts of ECG cables are intended to be connected only to the ECG electrodes. They should not be connected to any conductive parts of any objects including earth. 13.1 Electromagnetic compatibility (EMC) The PocketECG transmitter needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the user manual. WARNING. THE POCKETECG TRANSMITTER IS MR UNSAFE, AND SHOULD NOT BE USED IN ANY MAGNETIC RESONANCE ENVIRONMENT. WARNING. USE OF ACCESSORIES OTHER THAN THOSE SPECIFIED IN SECTION 6, WITH THE EXCEPTION OF THE ACCESSORIES SOLD BY THE MANUFACTURER OF THE POCKETECG TRANSMITTER AS REPLACEMENT PARTS FOR INTERNAL Page 53 of 118 COMPONENTS, MAY RESULT IN INCREASED EMISSION OR DECREASED IMMUNITY OF THE POCKETECG TRANSMITTER. Caution. Sources of electromagnetic radiation like:

portable and mobile radio frequency (RF) communications equipment (e.g. cellular phones, mobile radio), radio frequency identification systems (RFID) devices using one or more of the following wireless technologies: WiFi (IEEE 802.11), Bluetooth (IEEE 802.15), ZigBee (IEEE 802.15.4), WiMax(IEEE 802.16), Ant, etc, base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, metal detectors can affect the PocketECG transmitter. Caution. Sources of strong electromagnetic radiation such as radio transmitters, wireless personal transmitters working in the 80-2500 MHz frequency band may disturb the ECG signal and disturb the automated ECG signal analysis. It is recommended to keep the PocketECG transmitter as far as possible from all equipment combining RF transmitters. Try to reorient or/and relocate PocketECG transmitter when the ECG signal displayed on the screen of is partially masked by disturbing signal despite the ECG electrodes are properly placed on the patient skin. In case of further problems with the equipment operation, the medical service provider should be contacted for support. Page 54 of 118 PocketECG III device and any of its components should not be used for patient monitoring during any diagnostic tests or medical treatment performed using:

computed tomography (CT) systems, positron emission technology (PET), diathermy systems If the patient is going to be examined/treated using any of the above diagnostic systems while being monitored with the PocketECG III device, it is recommended to follow the instructions:

1. Contact your medical service provider or medical professional supervising your recording session to inform that you are going to remove the PocketECG transmitter for some time due to the medical examination/treatment. 2. Disconnect the ECG lead wires of the PocketECG transmitter from the electrodes placed on your body. 3. Leave the PocketECG transmitter in a place where it will not be exposed to any disturbing radiation generated by the medical system that is going to be used. Do not stop the recording session. 4. When the examination/treatment is finished, replace the electrodes if necessary and connect the lead wires of the PocketECG transmitter to the electrodes. Page 55 of 118 Guidance and manufacturer's declaration- electromagnetic emission The PocketECG transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the PocketECG transmitter should assure that it is used in such emission environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Group 1 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/

flicker emissions IEC 61000-3-3 Not applicable The PocketECG transmitter uses RF energy only for its internal function and transmission of the data through mobile phone network. The transmitter does not radiate any RF energy for diagnostic purposes. The PocketECG transmitter is suitable for use in all establishments, including domestic establishments. The device has no connection to the public low-

voltage power supply network. Guidance and manufacturer's declaration- electromagnetic immunity The PocketECG transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the PocketECG transmitter should assure that it is used in such emission environment. Immunity test IEC 60601 test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 6 kV contact 6 kV contact 8 kV air 8 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines 1 kV for input/output lines Not applicable Surge 1 kV line(s) to line(s) IEC 61000-4-5 2 kV line(s) to earth Not applicable

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in Not applicable Voltage dips, short interruptions, and voltage variations on power supply input lines. Page 56 of 118 Electromagnetic environment - guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. IEC 61000-4-11 UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 s Power frequency

(50/60Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. Guidance and manufacturer's declaration- electromagnetic immunity The PocketECG transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the PocketECG transmitter should assure that it is used in such emission environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the PocketECG transmitter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms d 17.1=

(

) P 3 V/m d d 17.1=

(

) P 80 MHz to 800 MHz 33.2=

(

) P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres

(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site Page 57 of 118 survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PocketECG transmitter is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the recorder. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Page 58 of 118 Recommended separation distances between portable and mobile RF communications equipment and the PocketECG transmitter The PocketECG transmitter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the PocketECG transmitter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PocketECG transmitter as recommended below, according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d

(W) 0.01 0.1 1 10 100 17.1=

(

) P d 17.1=

(

) P d 33.2=

(

) P 0.12 0.37 1.17 3.70 11.70 0.12 0.37 1.17 3.70 11.70 0.23 0.74 2.33 7.37 23.30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Page 59 of 118 B. P OCKETE CG PC CLIENT SOFTW ARE 14. EQUIPMENT REQUIREMENTS The PocketECG PC client software should be used with personal computers or tablets with Microsoft Windows XP, Vista or 7 OS installed. The PC/tablet should meet the following requirements:

At least 1 GB of RAM (2 GB recommended), 1 GHz CPU (1,5 GHz recommended), Free space on HDD at least 20 GB (40 GB recommended), Internet connection at least 512 kbps (downlink). 15. INSTALLATION In order to install the PocketECG PC Client software, the PC user is required to have administrative rights. The installation wizard will guide the user through the entire installation process which consists of a few steps. It is recommended to close all running applications before starting the installation. The PC client software is normally installed in the Program Files folder, however the user may select alternative directory. After user selects the destination folder, copying of the PocketECG files starts. During this step the user will be requested to accept installation of the following software packages that are distributed along with the PocketECG program: VC++ 2008 SP1 redistributable, Windows Mobile Device Center, Microsoft J#

Redistributable and Adobe Reader. These packages are required for proper PocketECG Client operation. During the installation of the PocketECG PC Client, a Windows registry entries are created which specify the server aliases along with their specific configuration parameters. Each alias consists of its own name and server parameters which are needed to establish a proper Page 60 of 118 connection. One of them is set as default and is used for first login action. Each installer is dedicated for one of the servers and normally there should be no need to change the default alias. It is impossible to create a new server alias using the PC Client software as all of them are included in the installer. If there is such need, it is necessary to contact service provider or a distributor of the PocketECG software. 16. DISTRIBUTION The PC client application is distributed to users using either a traditional method (DVD-R / CD-R), or electronically. The electronic distribution process is through password protected access to a SSL FTP server to obtain the installer. 17. OVERVIEW The PC client application allows for managing the recording sessions and reviewing the ECG data that was sent to the remote server by the patient monitors. The PC client user is able to manage ongoing sessions, review and modify the results of the ECG analysis and generate reports which summarize the detection results. After selecting a recording session in the Navigator window the user may start reviewing the ECG and the labeled arrhythmias. The ECG data, analysis results and application functions can be accessed through five viewing modes:

Page 61 of 118 Navigator main sessions manager window. Allows for selecting a particular session, which can be accessed through the following viewing modes:

Event View contains a list of ECG events /

arrhythmias detected by the system Full Disclosure allows for viewing the ECG waveform recorded during the monitoring Trends contains diagrams illustrating variations of the averaged heart rate and other ECG parameters Impressions and Findings notepad for entering comments which will be included in the generated reports Reports contains a list of reports which summarize the analysis results Garbage folder containing deleted recording sessions Archive folder containing archived recording sessions 17.1. Communication with remote server The PC Client application utilizes regular internet connection in order to perform its functions. The application monitors the state of the connection with the remote server. If connection cannot be established or is disturbed the No internet warning is displayed in the upper left corner of the screen. The internet connection is required only for transferring ECG data between the PC Client application and the remote server. Only those functions of the application that require internet communication are disabled when the problems with internet connection occurs. The user can still review the already downloaded ECG data, review trends, generate reports, etc. If "No internet" warning is displayed in the upper left part of the screen, the user should verify the state of internet connection. In order to do this, the user should run an internet browser and check whether it is possible to connect with any server and visit popular websites. Page 62 of 118 Following below instructions can be helpful in solving the problem with the remote server communication. If the internet browser responds properly o Check configuration of the firewall application installed on the PC. The firewall application should allow PocketECG Client to make outgoing connections. If there is no rule already created for the PocketECG Client software, the solution may be to create a rule allowing PocketECG Client software to make outgoing connections. o The PC Client stores information related to the connection quality to remote server in log files. The log files with *.csv extension are saved in LocalDataRoot\Log directory. In order to verify the quality of communication with remote server, open the log file using any spreadsheet application or simple text editor. The sample of the log file is presented below. Page 63 of 118 Ping test at:

Ping test duration:

alias ma1x3 ma1x1516 intermountain google 2011/Oct/19 10:15:20 AM 60 s successful failed avg succ. time (ms) 37 37 37 27 1 71.294 1 71.101 1 69.668 1 35.822 pings above 200 ms (%) 0.0 0.0 0.0 0.0 quality

(%) 97.4 97.4 97.4 96.4 The last column of the table presents quality of communication with the remote server. If the quality is low

(under 50%) for one or more of the servers, contact the PocketECG service provider or distributor for assistance. If the internet browser cannot connect to any web page. o Check whether all cables required for internet access are properly plugged into the PC and internet outlet. If the PC uses wireless access to the internet, verify that the wireless functions of the PC are enabled. o If the PC is a member of a local network, ensure that the local network operates correctly and is connected to the internet (check all devices like routers, access points, etc. ) o Use operating system utilities in order to diagnose the problem:

 press the right mouse button over the network icon in the notification area, and then select Diagnose and repair. Follow the instruction given by the operating system.

 open the Network Connections menu (StartControl PanelNetwork and InternetNetwork and Sharing CenterManage network connections). Follow the instructions given by the operating system. Page 64 of 118 If none of the abovementioned solutions help in establishing the reliable communication with remote server, contact the PocketECG provider or distributor for assistance. Page 65 of 118

18. NAVIGATOR 18.1. Introduction The Navigator window of the PC client application consists of a table listing recording sessions stored on the remote server and a toolbar with three menus (Fig. 14). Fig. 14 Navigator view Every row of the table corresponds to a single recording session. Information describing the recording sessions are presented in subsequent columns. The table has columns which provide the following information:

1) Location status informs the user about the location of the session data. There are five icons representing five available locations:

session data is located on a remote server session data is located on a local hard disk session data is being downloaded session data is located on the local hard drive and is not up to date - new data is ready to be Page 66 of 118 downloaded from the server. 2) Last update time indicates the time of the most recent transmission from the PDA to the remote server. 3) Company company name of the provider. 4) Message displays information related to the ECG data or status of the recording session. important events events defined as important are contained in files delivered to the server from the PDA monitor no-ekg the ecg signal has not been delivered to the server for more than 2 hours session ended session is finished report completed session is finished and report has been completed and finalized 5) Remarks place where users can write their own remarks e.g. expected recording duration. 6) Recorded time session duration. 7) Monitor type type of session. 8) 9) Columns with icons

( YES) and

(NO):

Completed informs whether the session has been already completed. Confirmed informs whether all events in a session have been confirmed. 10) Clear informs whether a session is free of questionable events. 11) First name patients first name, 12) Last name patients last name. 13) Medical supervisor supervisors name. 14) Technician 1 primary technicians name. Page 67 of 118 15) Technician 2 secondary technicians name. 16) Ordering physician ordering physicians name. 17) Interpreting physician interpreting physicians name. 18) Start time date and time when the session has started. 19) Record ID session ID, comprising of two segments separated by underscore. The first segment consists of the session starting time; the second segment contains the unique ID of the PocketECG transmitter used for monitoring. The rows of the table are highlighted with one of four colours. The colours indicate a role of the currently logged-in user (i.e. supervisor, technician, etc.). The colours denote the following roles:

Dark green Light green White Yellow means that the logged-in user is assigned to the session as a monitoring specialist (Technician 1/ Technician 2) means that the logged-in user is assigned to the session as a Medical supervisor (but not as a monitoring specialist at the same time), means that all specialists have been assigned to the session, and the logged-in user is not assigned to the session as a monitoring specialist or supervisor, means that at least one of the specialists for the session is missing and the logged-in user is not assigned to the session as a monitoring specialist or supervisor. Page 68 of 118 18.2. Navigator toolbar Recording sessions presented in the Navigator view may be filtered and/or sorted. The user can hide/show particular columns of the navigator table. All the abovementioned functions are available through three menus located in the application toolbar in the left upper part of the screen (Fig. 15):

Hide recording sessions - allows for selecting sessions that should not be presented in the Navigator, Sorting keys order - used for selecting the sorting order of the sessions presented in the Navigator, Columns visibility - allows for selecting the Navigator columns which are going to be hidden/shown Fig. 15 Menus: Hide recording sessions, Sorting key orders, Columns visibility The Hide diagnostic sessions menu contains criteria for hiding the sessions in the Navigator view. All of the sessions meeting particular Page 69 of 118 criterion are not displayed on the list. User may select one or more of the following criteria:

Confirmed, Unconfirmed, Clear, Unclear, Completed, Ongoing, Mine, Other specialists, Unassigned.

"Sorting keys order" menu allows for changing the order of the recording sessions that are sorted in the Navigator. The sessions are initially sorted based on the criterion placed on the top in the sorting keys order menu list. Then, all sessions meeting the first criterion are sorted based on the second criterion, etc. For example: if the first sorting criterion is Last name and the second is Start time, then all sessions for patients with the same last name, e.g. Smith, will be sorted by their start time. Instead of using "Sorting keys order" menu, the first sorting criterion may be selected by clicking on the column heading. The result is equivalent to moving the key to the top of the list in the Sorting keys order menu. Columns visibility menu allows for selecting the information that is going to be presented in the columns of the Navigator table. 18.3. Adding and editing patient and specialist data 18.3.1. Patients Page 70 of 118 The window Patients (Fig. 16) allows for adding and editing patients personal information. It can be opened by selecting Add/Edit patients option from the Tools Menu. Selecting option Assign/Edit patients from the context menu in the Navigator view, accessible when right-

clicking on the recordings list, opens a window which allows for assigning a patient to the highlighted recording session. Fig. 16 Patients window in Active patients mode Initially, the "Patients window shows a list of active patients. List of deleted patients can be accessed through Removed patients option. Options available in the Patients window include:

Add shows a form used for adding a new patient to the database and filling patient personal data, i.e. Last name, First name, Sex (male/female), Date of birth ID/SSN/PESEL No., phone, e-mail and address. Additional (descriptive) information Page 71 of 118 regarding the patient may be added/edited in the Auxiliary patient info section. Edit activates a form for editing personal data of a selected patient, Remove removes the selected patient from the list of active patients. The patient's data can be viewed after switching to the Removed patients mode (Fig. 17) Removed patients switches to the list of removed patients

("Remove patients" mode). Fig. 17 Patients window in Removed patients mode The Removed patients window (Fig. 17) contains the list of removed patients and two options:

Undelete restores the selected patient to the Active patients list, Page 72 of 118 Active patients switches the view to the Active patients mode. If a patient is already assigned to a session, right-clicking on the session and selecting Edit / View patient information opens a window where patient information can be viewed or edited (Fig. 18). The same form is opened when selecting the Edit in the Active patients view. Fig. 18Add/Edit Patient data window contains patients personal information. Page 73 of 118 18.3.2. Specialists The Specialists window is used for adding and editing specialists personal data. It can be opened by selecting Add/Edit specialists option from the Tools Menu specialists from the context menu. The Specialists window has been designed in a similar way to the Patients window (see Figs. 18 and 19). or by selecting Assign/Edit Fig. 19 Specialist window for adding/editing specialists data A single specialist may be assigned to multiple roles. The available roles in the system are:

Medical Supervisor, Technician 1, Technician 2, Page 74 of 118 Ordering physician, Interpreting physician, Administrator. The Detailed Settings button allows for setting up specific rights of the edited specialist. Specialists may have the following rights:

Ability to assign sessions, Full administration access, Specialists data modification, Patients data modification. Sign groups reports. Enroll for other group members Technicians interpretation modification Physicians interpretation modification The User settings tab allows for selecting how notifications about new reports are going to be delivered to the specialist. In addition, the user may decide whether the PC client should automatically download the ECG data for the assigned sessions. 18.3.3. Relations between specialists, patients and PocketECG transmitters The PC client application provides information about relations between specialists, patients and PocketECG transmitter. Every time a specialist and a PocketECG transmitter are assigned to the same recording session a relation between them is created. These relations may be edited using Add/Edit Specialists - transmitter relations window (Fig. 20). The list of all available specialists is located on the left side of the window. After selecting a specialist, the related patients, transmitters and other specialists appear on the right. These relations may be added or removed using Add and Remove buttons, respectively. Page 75 of 118 The list presented on the left side of the window, depending on the selected tab, contains specialist names, patient names or transmitter IDs. Fig. 20 Add/Edit specialist - transmitter relation window 18.4. Assigning patients / specialists to recording session Every time a new recording session is detected by the software, the PC client pops up a window for assigning patients and specialists (Fig. 21). The patients or specialists can be assigned to the new session through Select buttons (see Fig. 21). Page 76 of 118 Fig. 21 Window for assigning patients and specialists Patients and physicians may also be assigned to recording sessions using Navigator of the PC client application, by double-clicking on the table cells with patients or specialists name. Alternatively, it is possible to assign patients and specialists by right-clicking on the list and selecting the appropriate option from the context menu, i.e. Assign / Edit patient or Assign / Edit specialist. 18.5. Downloading and removing recording session data Session data is downloaded automatically under the following conditions:

the logged-in user is assigned to the session as a supervisor or technician new data is available on the server Page 77 of 118 the session has not yet been completed. It is possible at any time to download the selected recording manually by right-clicking on the session and selecting the Download option from the context menu. The icon column of the Navigator when the session data is successfully downloaded to the local hard drive. appears in the "Location status"

The recording session data may be removed either from the local hard disk drive (HDD) or marked as removed i.e. moved to the Garbage folder on the server and removed from all users HDDs. In order to remove the session data, right-click on the chosen session and select one of the following options:

Remove from local HDD removes recording session data from the local disk (available only for already downloaded sessions), Remove from server and all users HDDs marks the session as removed on the server and removes it from local disks of all users that have downloaded the session. Normally, in order to finish a recording session, an appropriate option should be selected through the transmitter. It is possible, however, to set the session status to finished through the PC client software by right-clicking on the selected session and selecting the Finish option from the context menu. 18.6. Remote communication with the transmitter After right-clicking on a session shown on the Navigator list, two main options related to the transmitters are available: Transmitter Settings and View transmitter log. After selecting the Transmitter Settings option, all arrhythmia settings of the PocketECG transmitter are displayed and are available for modification. Page 78 of 118 In order to display a window containing information related to the state of patient's equipment (Fig. 22), the "View Transmitter log"

option should be selected. Fig. 22 Transmitter Log Viewer window displaying session logs. The transmitter log provides the following information:

Log creation time, device battery level, SD memory left, Storage memory for programs, Available RAM, Spotted communication errors, The logs are generated by the transmitter's software every hour and transmitted to the PocketECG PC Client. In order to navigate through all generated logs the arrows displayed on the top of the window should be used. The single arrows (< and >) allow for switching Page 79 of 118 between subsequent logs. The double arrows (<< and >>) jump to logs generated every 24 h. 18.7. Communication with the SD card through USB The PC client application communicates with a SD card connected with the PC using the USB card reader. All recording sessions stored in the SD card are added to the list of displayed sessions presented by the Navigator which is indicated by the the user may select the following options for managing the data on the SD card:

icon. From the context menu, Download from SD card through USB - downloads session data from the SD card to the local hard drive, Remove from SD card through USB - removes a session from the SD card, Archive from SD card through USB - compresses session files and moves them to C:\LocalDataRoot \Archive folder. Page 80 of 118 19. EVENT VIEW 19.1. Introduction In order to get access to the ECG data presented in the Event View, Full Disclosure, Trends or Reports, the ECG data corresponding to the selected session must be earlier downloaded to the local hard drive. The results of the ECG signals analysis performed by the PocketECG transmitter are presented in the Event View of the PC client application

(Fig. 23). Fig. 23 Event view All detected events are presented in a table (every row corresponds to a single event). After selecting a particular event from the table, the relevant ECG strip is displayed in the upper sub-window. The table presented in the Event View has columns providing the following information which describe all events:

Time day number and the exact time of event occurrence, Page 81 of 118 Morphology index of recognized morphology class recognition is performed after clicking on the head of the column for sorting Rate heart rate during the event, Beats - number of successive heartbeats in a given event, Noise noise level in microvolts, Description events description, Status event status. There are four different options:

o Confirmed, o Unconfirmed, o Deleted, o Unclear. Strip - this field is selected when an ECG strip corresponding to the event will be shown in the report. Every line of the table presenting detected events is highlighted with one of the six colors corresponding to certain types of events:

Pink Red Heart rate Ventricular Green Supraventricular Yellow ST changes Grey Other White Marked beat A detailed description of the ECG annotations displayed in the upper part of the screen is given in section 20. Full disclosure. 19.2. Filtering and sorting the events list The list of events may be filtered by type - using the tree-organized filter located in the left part of the screen. Additionally, the list may be filtered by events status, day or morphology. The tree-organized list contains the following elements:

Page 82 of 118 Page 83 of 118 Critical & important events Patient triggered Heart rate o Fastest minutely HR o Average minutely HR o Slowest minutely HR o Asystole o Pause o Bradycardia o Missed beat Ventricular o Single Premature Beat o Couplet o Triplet o VT o Bigeminy o Trigeminy o IVR o AIVR o R on T Supraventricular o Single Premature Beat o Couplet o Triplet o SVR o AF o Bigeminy o Trigeminy ST Changes Operator selected Other o Electrode Contact Loss o Signal synchronization loss o Unrecognized o Marked beat. Filter by status allows for limiting the list of events to those with selected status and similarly "Filter by day" limits the list to events that took place during a selected day, or during all days. Filter by morphology limits the list to events containing beats with selected morphology index the filter activates after performing morphology grouping. 19.3. Events reviewing In order to change an event description, right-click on the event and select Edit description option from the context menu. All changes introduced to the description of events may be undone using Reset to default option. All beat annotations generated by the PDA can be modified using the following keyboard shortcuts:

o v to ventricular, o s to supraventricular, o a to atrial fibrillation, o n - to normal, o x to artifact. The Status of events may be modified in two ways:

by clicking on the Status cell on the event list the status changes in the following order: Unconfirmed Confirmed Deleted Unclear Unconfirmed, by selecting a given event on the list and using one of the keyboard keys:

o c changes status to Confirmed, o d changes status to Deleted, o u - changes status to Unclear, o shift+u changes status to Unconfirmed. o shift+g selects morphology group Page 84 of 118 If none of the events has "Unconfirmed" status, the recording session status is presented as "Confirmed" using the green Navigator list. If none of the events has "Unclear" status, the recording session status is presented as "Clear" using the green Navigator list. icon on the icon on the The ECG strip containing the detected event may be added to the following reports generated by the PC client application (Fig. 24):

Daily only, Cumulative and daily, Urgent, cumulative and daily. Fig. 24 Selection of strips for report 19.4. Navigation through the ECG recording The ECG waveform displayed in the upper part of the screen corresponds to the event marked on the list. To navigate through the ECG use the transport buttons (<, <<, >>, >) on the toolbar or the arrow keys of the keyboard:

Page 85 of 118 pressing the double arrow buttons on the toolbar moves the ECG record backward or forward by the length of the displayed strip (8 seconds), pressing the single arrow buttons moves the record backward or forward by 200 milliseconds, horizontal arrows on the PC keyboard move the record backward or forward by 200 milliseconds, 19.5. ECG display settings and transmitter settings Tools for changing the ECG waveform vertical scale and other parameters related to ECG display are described in section 20.3. Transmitter settings are described in sections 18.6. Page 86 of 118 20. FULL DISCLOSURE 20.1. Introduction The PocketECG PC Client provides access to full disclosure ECG recording. The ECG waveforms may be viewed using the Full Disclosure view of the PC client application, as shown in Fig. 25. Fig. 25 Full Disclosure view The timeline bar is displayed in the upper part of the screen. The user may click on the timeline bar in order to navigate directly to any time in the recording. The ECG waveform is displayed in normal size - as 8 s strip in the upper part of the screen and as a miniaturized signal in the bottom part of the screen (30 s of the signal in each row). User may click on the miniaturized ECG and the corresponding full size strip will be displayed in the upper part of the screen. The displayed strip is Page 87 of 118 indicated by yellow frame highlighting the corresponding miniaturized ECG fragment. The enlarged fragment of the Full Disclosure view containing the ECG strip is presented in Fig. 26. The PocketECG automatically detects and classifies QRS complexes. The annotations for all detected complexes are displayed above the ECG beats (2). The instantaneous heart rate is displayed between the ECG beat labels (3). Fig. 26 ECG waveforms presented in the upper part of the screen The PocketECG transmitter allows the patient to report symptoms manually. The ECG strip reported (marked) by the patient is presented in the Full Disclosure view with a long grey stripe marked with

"triggered by patient" label located under the ECG waveform (Fig. 27) Page 88 of 118 Fig. 27 ECG waveforms marked as "triggered by patient"

20.2. Navigation through the ECG recording The user can jump to the next selected ECG region or to heart beats meeting pre-defined criteria (Fig. 28). After clicking on the drop-down menu located in the left upper corner of the window it is possible to define the navigation criteria for the arrow buttons (Fig. 28). Fig. 28 Navigation menu If the Selected region option is selected, then the arrow buttons will skip to the next / previous selection onset / offset. The Strip position allows to navigate within selected event, from beats just before event, to middle part of event, and to beats just after event. Selecting "Beat type" option will show a window which will allow the user to specify beat-type and other beat related criteria for navigation (Fig. 29). Page 89 of 118 Fig. 29 "Skip to the next beat meeting the criteria" window The transport toolbar has three options:

1. skip by one hour, 2. skip by 30 seconds, 3. move the record by 200 ms periods. Pressing "Jump to" button opens a drop-down list with five options:

Time jumps to specified time, Max minutely HR jumps to the max HR strip, Higher minutely HR jumps to the next higher HR strip, Lower minutely HR jumps to the next lower HR strip, Min minutely HR jumps to the min HR strip. 20.3. ECG display settings and re-annotations The toolbar in the Full Disclosure view contains "EKG view mode"

menu. This menu allows for changing settings which influence the way the ECG waveform is displayed. The following options are available:

Page 90 of 118 Automatically scroll when new data arrives - when new data is received, strip corresponding to the last 8 seconds of the signal is presented automatically in the upper part of the screen and the miniaturized ECG is updated. Brighten/darken annotation boxes - used for brightening or darkening colors of the annotation boxes presented in the bottom part of the window. EKG baseline up/down - moves the ECG signal up or down, Increase/decrease the number of EKG rows - modifies the number of miniaturized ECG rows displayed in the bottom of the screen (and automatically changes the amplitude range of each row), Vertical scale - used for modifying the amplitude scale of the displayed full size ECG strip (upper part of the screen), R-R intervals - changes the R-R interval display format from beats per minute (BPM) to milliseconds (ms). Waveform - allows for filtering out/retaining the interferences and disturbances in the presented waveforms. There are also three other tabs located in the toolbar of the Full Disclosure view:

Add strip creates Operator selected event and allows for attaching the strip to the report, Filters - allows for switching between single and all-day displaying modes Annotations - there are two options under this menu item:

o Re-annotate/modify selection - opens a window presented in Fig. 30 (described below), o Modify status of events within selection Page 91 of 118 Fig. 30 "Re-annotate/Modify selection" window The window Re-annotate/Modify selection (Fig. 30) allows for modification of beat labels generated by the PocketECG transmitter software. The modification is applied to the annotations listed and checked in the left section of the screen. The filters located in the right section of the window allow for limiting the pre-selected beats based on HR criteria. The center section of the window allows for selecting the target beat annotations (to which the input beat annotations will be modified). It is possible to measure heart rate/R-R interval and signal peak-to-

peak amplitude manually using the ECG caliper (Fig. 31). In order to activate this tool, hold the mouse button and then move the cursor to the right adjusting the size of the displayed caliper. The measured parameters are displayed under the tool. Page 92 of 118 Fig. 31 Ruler tool Page 93 of 118 21. TRENDS Interactive trends illustrating variations of the averaged HR, AF burden, bradycardia burden, ventricular or supraventricular beats and runs count, as well as ST levels are available in the Trends view of the PC client software. The trends may be displayed in two modes:

Continuous trends - the upper part of the screen shows the full size ECG strip and the bottom part of the screen shows the trends (Fig. 32). Daily trends - each daily trend for each parameter is presented in a separate tab. Each day is presented in a separate row (Fig. 33) The control buttons and options located in the toolbar are similar to those already described in section 22. However, the buttons with double arrows (<< and >>) rewind the recordings by 24 hours. The buttons with single arrows rewind the waveforms by 1 hour. There are also additional buttons located in the upper toolbar, which are not available in the Full Disclosure view (Hide/show ECG strip and Zoom in/out). The daily trend of a particular parameter may be attached to the final report. If this is desired, mark the checkbox located in the right corner of every window containing trend diagrams. Page 94 of 118 Page 95 of 118 Fig. 32 Continuous trends Fig. 33 Daily trends 21.1. Acceleration trend The PocketECG transmitter sends to the remote server both: ECG and acceleration data. The acceleration data can be reviewed in the Trend view together with other trends e.g. heart rate. The sample ECG strip together with heart rate trend and acceleration trend is presented in Fig. 34. Page 96 of 118 Page 97 of 118 Fig. 34 Heart rate and acceleration trends 22. IMPRESSIONS AND FINDINGS Impressions and Findings is a notepad for user's remarks. The user is able to add comments related either to a single day of the recording or make general notes regarding the entire recording session. The arrows in the upper part of the screen allow for navigation through the notes. If "Day:x" is displayed between the navigation arrows, the added comment relates to day number x. The Day:All notice displayed between navigation arrows indicates that the comments refer to the entire recording session. The notes are attached to the reports generated by the PC client application the main note is attached to the summary report, while the daily notes are attached to the corresponding daily reports. Page 98 of 118 23. REPORTS 23.1. Introduction The Reports view consists of a table containing a list of all reports generated during the recording session (Fig. 35). There are five types of reports presented in the Reports view of application:

cumulative reports, end of study reports, daily reports, urgent reports, event reports. Fig. 35 Reports view The table containing generated reports has columns with the following headers:

Action contains Open button which allows to open the report, From defines the start time of the period covered by the report, To defines the end time of the period covered by the report, Page 99 of 118 Day defines the day covered by the report; All stands for the cumulative/end of study report, Description description of the report, Trends the diagrams selected using the Trends view of the application are attached to the report if this checkbox is selected, Strips the ECG strips chosen using the Event View of the application are attached to the report if this checkbox is selected, Full disclosure the miniaturized ECG waveforms are attached to the report if this checkbox is selected, Last publication date of last publication of the report with the author's name 23.2. Reports viewing In order to display a report, select it from the list and then choose the View report command (toolbar) or press the button Open. Double-

clicking on the particular row in the table also opens the corresponding report. The report contains the ECG strips previously selected to be attached using the Event View of the application. Furthermore, the notes added using the Impressions and Findings view are also included in the report. 23.3. Reports editing Reports may be modified manually after clicking the "Edit report statistics" button located in the toolbar of the application. The window for editing reports is presented in Fig. 36. Page 100 of 118 Fig. 36 Report editor All introduced modifications must be confirmed by clicking the

"Accept" button. In order to reject the changes and restore the original report select "Cancel" or "Cancel Edit". Page 101 of 118 24. GARBAGE The list of all recording sessions removed from the remote server is presented in the Garbage view of the PC client application. The list may be sorted and filtered using the pop-out menus located in the toolbar. The following menu options: Hide recording sessions, Sorting key order and Columns visibility are identical to the options available in the Navigator and described in detail in section 24. The recording sessions placed in the Garbage folder may be moved back to the main folder and further accessed using the Navigator. In order to restore a recording session press the right button on the PC mouse and then select the "Undelete" command. If the restored session has no specialists assigned, the window for assigning patients and specialist is displayed (see section 24.4). 25. ARCHIVE It is a list of all recording sessions which were located on the remote server and then archived in the Archive view of the PC client application. The list may be sorted and filtered using menu options located in the toolbar. The following menu options: Hide recording sessions, Sorting key order and Columns visibility are identical to the options available in the Navigator and described in detail in section 24. The recording sessions placed in the Archive folder may be moved back to the main folder and further accessed using the Navigator. In order to restore a recording session press the right button on the PC mouse and then select the "De-archive" command. If the de-archived session has no specialists assigned, the window for assigning patients and specialist is displayed (see section 24.4). 26. TOOLS MENU The main menu of the application called the Tools Menu is located in the upper left corner of the main window and is represented by the icon. The pop-out menu has the following options/commands:

Page 102 of 118 Change user Add / Edit specialists Add / Edit patients Clean local database Import session from hard disc Export billing data Open session directory Settings Logs out the current user and displays a window for entering a new login and password. Activates a window for adding and editing specialists personal data, as described in section 18.3.2. Activates a window for adding and editing patients personal data, as described in section 18.3.1. Removes both: ECG data and recording session files already downloaded to the hard drive and initiates a restart of the application. Activates a window for choosing the session data that are going to be imported from the local hard drive. Saves the ECG data of selected session to a csv file. Opens the folder which stores all the session files. Opens a window which contains the global setting related to the remote server and the user interface. Clear all re-annotations Clears all re-annotations introduced by the user during reviewing. Archive all from SD card Moves data from recording sessions stored on the SD card (connected through the USB card reader with PC/tablet) to the Archive folder of the PC client. Add/Edit Specialist/transmitters relations Opens a window for editing specialists/user/transmitter relations, as described in section 18.3.3. Page 103 of 118 Export action log Exports a list of actions performed by the user for the highlighted recording session along with time stamps. Load data from backup Export ECG Signal data Exports the signal data to a text file. Annotations data Exports the ECG annotations to a text file. Page 104 of 118 C. A DDI TIONAL INFORMA TION 27. MEDICAL INCIDENT Caution. Should a medical incident take place, as defined by the medical devices act of February 2, 2011, notify the manufacturer immediately. MEDICALGORITHMICS SA Jerozolimskie 81 02-001 Warsaw, Poland tel./fax.: + 48 22 825 1249 e-mail: technical@medicalgorithmics.com Page 105 of 118 28. TROUBLESHOOTING Problem Probable cause(s) and solution It is impossible to turn on the PocketECG transmitter. The ECG signals displayed by the PocketECG transmitter are of low amplitude and disturbed. The battery is discharged. Replace the battery with a fully charged one. Poor skin preparation or the electrodes past their use-by date. Remove hair and grease from where the electrode is to be attached and use single-

use electrodes designed for long-term ECG monitoring. The recording session cannot be initiated if:

- the SD card is not installed It is impossible to start new recording session.

- the device is powered from backup battery If you cannot initiate recording session after checking abovementioned issues, contact PocketECG service provider. The memory card is full. Format the memory card. Recording session stopped unintentionally. The monitoring data is not stored properly the application notifies about errors. The writing and/or reading speed of the memory card is not sufficient. Use memory cards of at least 100 kbps reading and writing speed. The device screen cannot be unlocked. Press the service provider logo for 3 seconds and then type the unlocking code:

1 2 3 6. The recording session Check the session status in the 'supervisor Page 106 of 118 has been successfully started on the PocketECG transmitter, but it is not listed in the PocketECG client application. view' About Session info- the '[OK]'

text string indicates that the wireless connection between PocketECG transmitter and remote server has been successfully established. If instead of '[OK]'

an error code is displayed in the brackets, the transmitter cannot connect to the remote server. Ensure that the Internet connection is properly configured on the phone and that it is within the mobile network range. If the '[OK]' status is displayed and the newly started recording session still cannot be found in the PocketECG Client application, the PC operating PocketECG Client does not have an active Internet connection. Consult your PocketECG distributor or service provider for support. The recording session has been finished, but the mobile phone network is not working

(ECG data cannot be transmitted) or internet is inaccessible due to its infrastructure failure. Finish the recording session and remove SD card from the PocketECG transmitter. Use micro SD card reader equipped with USB interface and connect it to the PC operating the PocketECG Client application and download the ECG data from the SD card to the local hard drive (refer to subsection 18.7). The PocketECG Client application cannot communicate with the remote server - the ECG data cannot be downloaded. Refer to subsection 17.1 Page 107 of 118 29. TECHNICAL PARAMETERS Model Type PocketECG III PECGT-III Wireless communication Quad band GSM EDGE, UMTS 850 / 1900

/ 2100MHz. The wireless data transmission technologies: GPRS, EDGE, HSDPA, HSUPA. Group/class according to CISPR 11 I/B Powered by a Lithium-ion battery 3.7V type: PECGB-

III (1700 mAh) Power consumption

< 2.5A (in transmission mode) Working time at least 24 hours Input impedance

> 10 Mohm CMRR Sampling rate

> 60 dB 300 Sa/s Registered signal band Input dynamic range Acceptable constant component 0.05 - 60 Hz

+/- 5 mV

+/- 300 mV 1) Temperature: 0 C +43C (32 to 1090F );

2) Relative humidity range of 15 % to 93 %, non-condensing;

3) Atmospheric pressure: 700 hPa to 1060 hPa. 1) Temperature: -20 C +60C (-4 to 140F) 2) Relative humidity up to 93 %, non-

condensing. 2) Atmospheric pressure: 700 hPa to 1060 hPa Operating conditions Transport conditions, Storage conditions, Storage between uses conditions Page 108 of 118 Dimensions Weight (with battery) 161 g 167x 79 x 14,5 mm (without cable) Page 109 of 118 30. SERVICE Service is provided only by Medicalgorithmics S.A. In case of any product malfunction a device shall be returned directly to manufacturer to the following address:

MEDICALGORITHMICS S.A. Jerozolimskie 81 02-001 Warsaw, Poland tel./fax.: + 48 22 825 1249 e-mail: technical@medicalgorithmics.com 31. DECLARATION OF CONFORMITY If you would like to receive the declaration of conformity, contact with the manufacturer on the following address:

MEDICALGORITHMICS S.A. Jerozolimskie 81 02-001 Warsaw, Poland e-mail: technical@medicalgorithmics.com 32. LIMITED WARRANTY STATEMENT This limited warranty shall apply to a product (Product) supplied by MEDICALGORITHMICS. MEDICALGORITHMICS warrants that at the time of its original purchase the product is free of defects in materials and workmanship (Limited Warranty). THIS LIMITED WARRANTY DOES NOT AFFECT YOUR STATUTORY RIGHTS. This Limited warranty is subject to the following terms and conditions:

1. This Limited Warranty is given only to the original purchaser of the Product (Customer). This Limited Warranty may, however, be transferred to any individual to whom the Product is sold, where MEDICALGORITHMICS has consented in writing to the transfer (and Page 110 of 118 MEDICALGORITHMICS will not unreasonably refuse consent). It shall neither exclude nor limit a) any statutory rights of the Customer or b) any of the Customers rights against the seller/dealer of the Product. 2. This Limited Warranty shall last for twelve (12) months from the date of original purchase for the ECG transmitter, and twelve (12) months for accessories (whether included in the ECG transmitter sales package or sold separately) other than the media, on which software is provided, CD-ROM, memory card (Warranty Period). Customer shall present the PROOF OF PURCHASE and the SERIAL NUMBER OF POCKETECG TRANSMITTER upon claiming this Limited Warranty. This Limited Warranty is only valid and enforceable in the countries where the Product is sold. However, if you have purchased the Product in a member state of the European Union, Iceland, Norway, Switzerland or Turkey and MEDICALGORITHMICS originally intended the Product for sale in one of these countries, this Limited Warranty is valid and enforceable in all of the above listed countries. Moreover, if Product is purchased in places other than those stated above, MEDICALGORITHMICS will attempt to repair such Product but cannot guarantee the outcome. Warranty service availability and response times may vary from country to country and may also be subject to a registration requirement in the country of purchase. 3. Throughout the Warranty Period MEDICALGORITHMICS or its authorized agent will, at their discretion repair or replace a defective Product free of charge, subject to Clause 6. Repair or replacement may involve the use of functionally equivalent reconditioned unit. MEDICALGORITHMICS will return the repaired Product or will replace it with another functionally equivalent Product in good working condition. All replaced faulty parts or components will become the property of MEDICALGORITHMICS. Page 111 of 118 4. This Limited Warranty applies only to the hardware components of the Product as originally supplied and does not apply to any software or other equipment. 5. If MEDICALGORITHMICS repairs or replaces the product, the repaired or replaced Product shall continue to be warranted for the remaining time of the original Warranty Period or for three (3) months from the date of repair or replacement, whichever is longer. 6. THIS LIMITED WARRANTY SHALL NOT APPLY IF:

a) the Product serial number, the accessory date has been removed, erased, defected, altered or is illegible; or b) deterioration of the Product is due to normal wear and tear; or c) the Product was used other than as described in the user manual, subjected to rough handling, exposed to moisture, dampness or extreme thermal or environmental conditions or a rapid change in such conditions, corrosion, oxidation, subjected to unauthorized modifications or connections, unauthorized opening or repair, repair by use of unauthorized spare parts, accidents, forces of nature, or other actions beyond the reasonable control of MEDICALGORITHMICS (including but not limited to deficiencies in consumable parts) unless the defect was caused directly by defects in materials or workmanship. This Limited Warranty does not cover physical damage to the surface of the Product; or d) the defects result from the fact that the battery has been short-

circuited or from the fact that the seals of the battery enclosure or the cells are broken or show evidence of tampering or from the fact that the battery has been used in equipment other than those for which it has been specified; or e) the Product software needs to be upgraded due to changes in cellular network parameters; or Page 112 of 118 f) the defect was caused by the fact that the Product was used with or connected to an accessory not approved or provided by MEDICALGORITHMICS or used not as intended and where it can be shown by MEDICALGORITHMICS that such defect is not the fault of the Product itself. 7. Your Product may contain country specify elements, if the Product has been re-exported from its original destination country to another country, the Product may contain country specific elements that are not considered to be a defect under this Limited Warranty. CUSTOMER MUST NOTIFY MEDICALGORITHMICS OR A MEDICALGORITHMICS AUTHORIZED SERVICE AGENT OF A CLAIM UNDER THIS LIMITED WARRANTY AND OF THE ALLEGED DEFECT WITHIN A REASONABLE TIME AFTER NOTICING THE DEFECT AND IN ANY EVENT NO LATER THAN BEFORE THE EXPIRY OF THE WARRANTY PERIOD. 8. In the event of Product failure, the Customer should take the following actions:

a) refer to the user manual in order to identify and possibly correct the problem, b) if the problem cannot be resolved by referring to the user manual the Customer should contact the dealer where the Product was purchased, c) before the Customer contacts the MEDICALGORITHMICS service agent, please ensure the following information is at hand:

- The model and serial number of the Product,

- The customers full address and contact information.

- A copy of the Customers original invoice, receipt or bill of sale for the purchase of the Product. MEDICALGORITHMICS will provide the Customer with instructions regarding how and when the defective Product should be returned. MEDICALGORITHMICS will pay both for the return of the defective product Page 113 of 118 to MEDICALGORITHMICS and for sending the repaired Product back to the Customer if the Defective Product is within the Warranty Period. 9. THIS LIMITED WARRANTY STATES THE ENTIRE WARRANTY GIVEN BY MEDICALGORITHMICS TO THE CUSTOMER. IN NO EVENT SHALL MEDICALGORITHMICS BE LIABLE UNDER THIS LIMITED WARRANTY FOR LOSS OF PROFIT, LOSS OF ANTICIPATED SAVINGS, LOSS OF DATA OR INDIRECT LOSS OF USE OF THE PRODUCT OR ANY ASSOCIATED EQUIPMENT, INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES OF ANY NATURE WHATSOEVER TO THE FULLEST EXTENT THAT THOSE LOSSES OR DAMAGES CAN BE DISCLAIMED BY LAW. In any case MEDICALGORITHMICS and its suppliers entire liability under any provision of this Limited Warranty shall be limited to the amount actually paid by the Customer for the hardware. MEDICALGORITHMICS does not exclude or limit liability for personal injury or death resulting from its own negligence, for defects in the Product arising out of its or its manufacturers negligence, under Part I of the Consumer Protection Act 1987 or for fraudulent misrepresentation. The laws of some countries prohibit Medicalgorithmics from excluding or limiting its liability. In such cases, the exclusions and limitations of liability in this Limited Warranty will not apply. This Limited Warranty gives the Customer specific legal rights; the Customer may also have other rights, which may vary from country to country. This limited warranty does not affect the Customers statutory rights in law specific to the country of purchase, such rights remain protected. 33. SOFTWARE LICENSE AGREEMENT Terms and definitions:

AGREEMENT this License Agreement. Page 114 of 118 PRODUCER Medicalgorithmics S.A. LICENSEE party that is entering into this Agreement with Producer PRODUCT software, data and related material contained in the PocketECG package PRODUCER IS WILLING TO LICENSE PRODUCT TO LICENSEE ONLY ON THE CONDITION THAT LICENSEE ACCEPTS ALL THE TERMS AND CODITIONS STATED IN THIS AGREEMENT. BY INSTALLING OR USING THE PRODUCT THE LICENSEE INDICATES ACCEPTANCE OF THIS AGREEMENT. RESER V A TION OF O WNERS HIP A ND GRANT OF LIC ENSE All rights not specifically granted in this Agreement are reserved to Producer. Product is owned by Producer and its third party licensor(s) and is protected by copyrights laws. Producer and its third party licensor(s) retain exclusive rights, title and ownership of the copy of the Product. Hereby Producer grants to Licensee a personal, nonexclusive nontransferable license to use Product on the terms and conditions of this Agreement. Licensee agrees to use every reasonable effort to protect Product from unauthorized use, reproduction, distribution or publication. PERMITTED USES a) Licensee may install and use Product on only one computer system and only if that computer is for Licensees own internal use and constitutes Licensees own property. b) Licensee may make two backup copies of the Product. USES NOT PERMITTED Page 115 of 118 a) Licensee shall not reverse, engineer, decompile, or disassemble the software contained in Product. b) Licensee shall not remove or obscure Producer copyright or trademark notices. TERMINATION Licensee may terminate this Agreement at any time by returning Product in its entirety to Producer. Producer may terminate this Agreement in case of the Licensees material breach of this Agreement. If Agreement is terminated after the warranty period, Producer will not reimburse the purchase price. LIMITED WARRANTY Producer warrants that the media upon which Product is provided will be free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of receipt. If a defect is found that was not caused by improper use, Producer at its own discretion will exchange Product for a defect-free or reimburse the price paid by Licensee. Producer made every effort to provide flawless operation of Products functions. Nonetheless Licensee understands that Product may contain some errors, defects, omissions or nonconformities. Therefore Producer and the respective third party licensor(s) discourage Licensee from relying exclusively on data generated by the Product. EXC LUSIVE REMEDY AND LIMIATATION OF LIABILITY Producers entire liability and Licensees exclusive remedy during the warranty period shall be the return of the license fee paid for the Product or exchange of Product as described in the Limited Warranty above. Producer shall not be liable for indirect, incidental or consequential damages related to Licensees use of Product, even if Producer is advised of the possibility of such damage. Page 116 of 118 WAIVERS No failure or delay by Producer in enforcing any right or remedy under this Agreement shall be construed as a waiver of any future or other exercise of such right or remedy by Producer. ORDER OF PRECEDENCE Terms expressed in this Agreement have precedence over those expressed in purchase order or other purchase arrangements unless agreed otherwise. GOVERNING LAW All rights and duties under this Agreement shall be governed by the commercial law of the country where the license is purchased with exception of copyright, patent, and trademark issues. Those shall be governed by the laws of Poland and the applicable international treaties and conventions. ENTIRE AGREEMENT The parties agree that this Agreement constitutes the sole and entire agreement of the parties as to the matter set forth herein and supersedes and arrangements between Producer and Licensee and is effective, valid and binding upon parties. understandings agreements, previous any Page 117 of 118 0197 Page 118 of 118